Please , Can anybody tell me from where I will get the information regarding the Validation of the Lyophiliser and Isolators. or anybody have the document regarding this.
best source is the actual manual for the equipment.
It will state all equipment/software installation guidelines. Ur IQ needs to ensure that all these steps were carried out.u can add some of ur own common sense guidelines, which u think are important
The oq will check if its operating properly like:
is it switching on./off
if its components are working
user is able to login etc without getting into exact numbers
Pq will check for specific numbers. Try to get an executed IQ OQ from ur firm and build ur new iq oq in their format.
Hope this helps.
Thanks a lot Yogi